1. Field of the Invention
This invention relates to surgery and more particularly to light, thermal and electrical applications comprising electrical systems. The electrical system is commonly called a pacemaker.
2. Description of the Prior Art
The field of medical technology has experienced unprecedented developments in the last several decades. Some of the most dramatic advances in the medical field have occurred in the understanding and control of the human heart. The development of the pacemaker has solved some of the heretofore unsolvable problems of heart disease and has extended the lives of thousands of patients. Presently, a surgical implant of a pacemaker and pacemaker electrode requires approximately 1-2 hours of surgical time. This surgical procedure comprises sectioning through the tissue layers of the patient down to the cephalic vein. An incision is made in the cephalic vein and the electrode tip is inserted through the incision and directed toward the heart. Further insertion of the electrode through the cephalic vein enables entry of the electrode tip into the right ventricle of the heart. The electrode is then tied to the body tissue and a second surface incision is made for receiving the pacemaker pulse generator. The electrode is connected to the pulse generator by a special plug-receptacle combination. The pacemaker is then implanted within the patient.
The cephalic vein is located beneath the layers of the pectoralis muscle on the chest wall. Many times a large physical incision and a considerable amount of dissection is required to isolate the cephalic vein. Not infrequently, the cephalic vein is too small to accommodate the size of the state-of-the-art pacemaker electrodes. In such a case, more extensive dissection must be made in following the cephalic vein to its origin. The cephalic vein extends beneath the clavicle, running ultimately to the subclavian vein. The subclavian vein is presently inaccessible by known surgical techniques to direct surgical insertion of a permanent electrode.
Others in the prior art have inserted temporary electrodes directly into a patient through the use of a surgical needle. The needle is introduced into a patient and the electrode tip is inserted through a center passage in the needle to enter an organ of the patient. The other end of the electrode is temporarily connected to an electronic device or the like.
Pacemaker electrodes generally have an electrode tip and electrode plug on opposite ends thereof. Accordingly, a permanent pacemaker electrode cannot be inserted through a needle since the needle cannot be removed over the electrode plug. The electrode cannot be electrically connected to the electrode plug by soldering or other means after the electrode is inserted since the electrode must be sterile.
The present state of the art has not provided an apparatus nor a method for quickly and efficiently inserting a permanent pacemaker electrode into the heart cavity without sectioning to a vein of a patient. The prior art has provided rapid insertion for only temporary electrodes into a patient.
Therefore it is an object of this invention to provide an apparatus and a method which overcomes the aforementioned inadequacies of the prior art devices and methods and provides an improvement which is a significant contribution to the advancement of the pacemaker art.
Another object of this invention is to provide a method and an apparatus for implanting a permanent pacemaker electrode wherein the electrode is inserted into a vein in fluid communication with the heart without sectioning the patient to gain access to the vein.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of the patient utilizing an introducer sleeve in cooperation with a needle. The needle is inserted through the exterior skin of the patient to puncture the internal organ. The introducer sleeve is inserted into the puncture in the internal organ and the needle is removed. The electrode is then inserted through the introducer sleeve enabling the introducer sleeve to be withdrawn through a severing in the sleeve wall along the length thereof.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient incorporating an introducer sleeve made of a substantially rigid plastic or fiberous material which has a severing means for severing the sleeve wall along the entire length thereof. The severing in the sleeve allows the sleeve to be removed from the electrode over an electrode plug at the terminal end of the electrode.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient wherein the introducer sleeve includes perforations along the length thereof for enabling the sleeve to be severed to remove the sleeve over the electrode plug at the terminal end of the electrode.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient incorporating an introducer, an introducer sleeve, a guide wire and a needle.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient comprising an introducer sleeve which is severed along the entire length thereof except the tip portion of the introducer sleeve.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient wherein an introducer sleeve is insertable on the outer surface of a needle into the internal organ of the patient.
Another object of this invention is to provide a method and an apparatus for inserting a permanent electrode into an internal organ of a patient wherein an introducer and an introducer sleeve is inserted by a guide wire into the internal organ of the patient.